Reliability of a Top Mount Actuation Indicator With Levalbuterol MDI in Adult and Pediatric Subjects With Asthma or COPD
NCT ID: NCT00583986
Last Updated: 2012-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
150 participants
INTERVENTIONAL
2005-09-30
2006-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Levalbuterol HFA MDI with top mounted actuation indicator
Levalbuterol HFA MDI with top mounted actuation indicator
Levalbuterol HFA MDA with top mounted actuation indicator
Interventions
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Levalbuterol HFA MDI with top mounted actuation indicator
Levalbuterol HFA MDA with top mounted actuation indicator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject must have stable baseline asthma or COPD and have been using a beta-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 months.
* Subject must be in good health with the exception of their reversible airways disease and not suffering from any chronic condition that might affect their respiratory function.
Exclusion Criteria
* Subject who has a history of hospitalization for asthma or COPD within 45 days.
* Subject with currently diagnosed life-threatening asthma or COPD, defined as a history of asthma or COPD episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 months prior.
* Subject with supplemental oxygen use
* Subject with a history of cancer
* Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases, or seizure disorders that currently are not well controlled by medication.
* Subject with asthma with a greater than 10-pack per year history of cigarette smoking or use of any tobacco products within 6 months.
4 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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John Hanrahan, M.D.
Role: STUDY_CHAIR
Sumitomo Pharma America, Inc.
Locations
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Encinatas, California, United States
Huntington Beach, California, United States
Mesa, California, United States
Orange County, California, United States
Riverside, California, United States
San Diego, California, United States
San Jose, California, United States
Viejo, California, United States
Walnut Creek, California, United States
Tamarac, Florida, United States
Russells Mills, Massachusetts, United States
Commack, New York, United States
Rochester, New York, United States
Elizabeth City, North Carolina, United States
Oklahoma City, Oklahoma, United States
Medford, Oregon, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Simpsonville, South Carolina, United States
Chattanooga, Tennessee, United States
Austin, Texas, United States
Braunfels, Texas, United States
San Antonio, Texas, United States
Burke, Virginia, United States
Richmond, Virginia, United States
Morgantown, West Virginia, United States
Countries
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Related Links
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Patient's Instructions for Use
Other Identifiers
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051-357
Identifier Type: -
Identifier Source: org_study_id
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